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Impulse Dynamics N.V.

http://www.impulse-dynamics.com/us/

Latest From Impulse Dynamics N.V.

Final 2020 CMS Outpatient, ASC Payment Rules Broaden Patient Access To Medtech

The US Medicare agency is allowing more device procedures to be conducted at outpatient hospitals and ambulatory surgical centers (ASC), while approving several new devices for passthrough payments for three years under its Outpatient Prospective Payment System and ASC payment system final rule for 2020, released on 1 November.

Policy Medicare

FDA Approves Impulse Dynamics’ Optimizer Smart For Heart Failure As Breakthrough Device

The Optimizer Smart implantable pulse generator delivers Cardiac Contractility Modulation therapy to improve the quality of life and functional status of patients with advanced heart failure who are not indicated for cardiac resynchronization therapy. The agency granted Optimizer Smart as a Breakthrough Device because of its potential to improve outcomes for heart failure patients without other options.

Approvals Commercial

Global Device Approvals Snapshot For March 18 - March 25, 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week FDA approved Impulse Dynamics’ Optimizer Smart impulse generator for cardiac contractility modulation therapy, CardioFocus’ HeartLight Endoscopic Ablation system earned a CE Mark, and Health Canada approved a new version of DarioHealth’s smart-phone compatible continuous glucose monitor.

Approvals Research & Development

FDA Device Panel Delivers Thumbs Up For Breakthrough Heart-Failure Device

A US FDA panel overwhelmingly supported a heart-failure device designed to use cardiac contractility modulation to improve heart function. The Optimizer Smart system from Impulse Dynamics is apparently the first in FDA’s Breakthrough Devices program to go before an advisory panel.

Advisory Committees FDA
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Company Information

  • Industry
  • Medical Devices
    • Implantable Devices
  • Other Names / Subsidiaries
    • Hobart Group
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